Impact of Pringle Maneuver on Postoperative Gallbladder Diseases After Hepatectomy

Official title

Impact of Pringle Maneuver on the Occurrence of Postoperative Gallbladder Diseases After Hepatectomy: A Multicenter Retrospective Cohort Study

Overview

The liver is an organ with a rich blood supply. During liver surgery (hepatectomy), surgeons often temporarily clamp the blood vessels supplying the liver to maintain a clear surgical field and reduce bleeding. This common technique is known as the Pringle maneuver. However, this maneuver also temporarily cuts off the blood supply to the gallbladder. Currently, doctors debate whether to routinely remove a healthy gallbladder during liver surgery to prevent future gallbladder problems, or to preserve it. The primary purpose of this multicenter retrospective cohort study is to evaluate whether using the Pringle maneuver during liver surgery increases the risk of patients developing gallbladder diseases (such as gallstones or inflammation) later on. Researchers will review the past medical records of patients who underwent liver surgery with their gallbladder preserved between January 2012 and January 2022. By comparing patients who had the Pringle maneuver with those who did not, the study aims to provide reliable clinical evidence to help surgeons make better decisions about whether to preserve or remove the gallbladder during liver surgery.

Detailed description

Hepatectomy is a primary curative treatment for various liver solid lesions. Given the liver's extensive vascular network, effective inflow occlusion is crucial during hepatectomy to minimize intraoperative blood loss and shorten operative time. The Pringle maneuver, which involves the temporary clamping of the hepatic artery and portal vein, is the most frequently utilized technique for this purpose. Despite its effectiveness in controlling hemorrhage, the Pringle maneuver inevitably induces ischemic-reperfusion injury to the hepatobiliary system and interrupts the blood supply to the gallbladder. This interruption may theoretically contribute to a higher risk of postoperative gallbladder diseases, including cholelithiasis and chronic cholecystitis.

In current clinical practice, the management of a disease-free gallbladder during hepatectomy remains controversial. Some surgeons advocate for simultaneous prophylactic cholecystectomy to prevent future gallbladder-related complications, whereas others prefer gallbladder preservation when no overt pathological changes are present. To date, robust evidence regarding the definitive impact of the Pringle maneuver on the incidence of postoperative gallbladder diseases is lacking.

This multicenter retrospective cohort study is designed to bridge this evidence gap. Clinical data will be retrospectively extracted for patients who underwent elective hepatectomy with gallbladder preservation across multiple major clinical centers in China from January 2012 to January 2022. The study will comprehensively evaluate and analyze baseline demographic profiles, preoperative laboratory indicators, tumor characteristics, intraoperative parameters (specifically the application and duration of the Pringle maneuver), and postoperative outcomes. The primary focus is to assess the occurrence of postoperative gallbladder diseases and identify potential risk factors associated with this complication. The findings are expected to provide high-quality, real-world evidence to guide surgical decision-making regarding gallbladder management during hepatectomy.

Interventions

• Procedure Pringle maneuver
  A surgical technique utilized during hepatectomy that involves the temporary clamping of the hepatic hilum to control and reduce intraoperative blood loss.

Primary outcome measures

• Cumulative Incidence of Postoperative Gallbladder Diseases [Time frame: Up to 14 years (From the date of surgery to the follow-up cutoff date in January 2026)]

Secondary outcome measures (1)

• Risk Factors Associated with Postoperative Gallbladder Diseases [Time frame: Up to 14 years (From the date of surgery to the follow-up cutoff date in January 2026)]

Eligibility criteria

Inclusion criteria

• Aged 18 to 85 years.
• Definitive diagnosis of hepatic solid lesions confirmed by imaging (such as CT, MRI, or ultrasound) and/or pathology.
• Underwent elective hepatectomy with gallbladder preservation.
• Preoperative liver function evaluated as Child-Pugh class A or B.
• Preoperative American Society of Anesthesiologists (ASA) physical status classification of I, II, or III.

Exclusion criteria

• Preoperative evaluation indicating pre-existing biliary tract diseases (e.g., cholelithiasis, biliary inflammation, neoplastic lesions).
• History of previous upper abdominal surgery.
• Application of non-hepatic inflow occlusion methods during surgery (e.g., hemihepatic vascular occlusion, selective segmental vascular occlusion).
• Personal history of long-term use of hormone replacement therapy, somatostatin and its analogues, or oral contraceptives.
• Loss to follow-up or missing critical data postoperatively.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 8 centers

• The First Affiliated Hospital of University of Science and Technology of China — Hefei
• Xinqiao Hospital of Army Medical Universit — Chongqing
• Sun Yat-sen University Cancer Center — Guangzhou
• Zhujiang Hospital of Southern Medical University — Guangzhou
• The First Affiliated Hospital of Harbin Medical University — Harbin
• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
• Nanjing Drum Tower Hospital — Nanjing
• Tianjin Medical University Cancer Institute and Hospital — Tianjin

Identifiers

NCT: NCT07452848 · JHuang20236

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗